恆瑞醫藥(600276.SH)：獲得藥物臨牀試驗批准通知書
格隆匯 11 月 12日丨恆瑞醫藥(600276.SH)公佈，公司近日收到國家藥品監督管理局(“國家藥監局”)核准簽發的《藥物臨牀試驗批準通知書》，並將於近期開展臨牀試驗。
根據《中華人民共和國藥品管理法》及有關規定，經審查，2020年9月2日受理的蘋果酸法米替尼膠囊符合藥品註冊的有關要求，同意開展用於晚期腎細胞癌治療的臨牀試驗，具體為：評價卡瑞利珠單抗聯合法米替尼對比卡瑞利珠單抗單藥或研究者選擇治療方案治療晚期腎細胞癌的有效性和安全性的隨機、陽性對照、開放、多中心、III期臨牀試驗(方案編號：SHR-1210-III-326)。
根據《中華人民共和國藥品管理法》及有關規定，經審查，2020年9月2日受理的注射用卡瑞利珠單抗符合藥品註冊的有關要求，同意開展用於晚期腎細胞癌治療的臨牀試驗，具體為：評價卡瑞利珠單抗聯合法米替尼對比卡瑞利珠單抗單藥或研究者選擇治療方案治療晚期腎細胞癌的有效性和安全性的隨機、陽性對照、開放、多中心、III期臨牀試驗(方案編號：SHR-1210-III-326)。
蘋果酸法米替尼膠囊是公司創新研發的小分子多靶點酪氨酸激酶抑制劑。經查詢，蘋果酸法米替尼目前國內外有索拉非尼、舒尼替尼、培唑帕尼等多種同類產品獲批上市。索拉非尼由拜耳公司開發，於2005年在美國獲批上市；舒尼替尼由輝瑞公司開發，於2006年在美國獲批上市；培唑帕尼由諾華研發，於2009年在美國獲批上市。目前三款多靶點抑制劑均已在國內獲批上市。經查詢，索拉非尼、舒尼替尼、培唑帕尼的2019年全球銷售額約為21.59億美元。
注射用卡瑞利珠單抗是人源化抗PD-1單克隆抗體，可與人PD-1受體結合並阻斷PD-1/PD-L1通路，恢復機體的抗腫瘤免疫力，從而形成癌症免疫治療基礎。經查詢，目前國外有3款PD-1單克隆抗體獲批上市，分別為帕博利珠單抗(默沙東，商品名可瑞達)，納武利尤單抗(百時美施貴寶，商品名歐狄沃)和cemiplimab(再生元製藥，商品名Libtayo)。帕博利珠單抗和納武利尤單抗均已在國內獲批上市。除恆瑞醫藥外，國內另有3款PD-1單克隆抗體獲批上市，分別為特瑞普利單抗(上海君實，商品名拓益，2018年獲批)，信迪利單抗(信達生物，商品名達伯舒，2018年獲批)和替雷利珠單抗(百濟神州，商品名百澤安，2019年獲批)。經查詢，2019年抗PD-1抗體全球銷售額約為188.09億美元。
截至目前，蘋果酸法米替尼膠囊累計已投入研發費用約為12601萬元，注射用卡瑞利珠單抗累計已投入研發費用約為128411萬元。
根據我國藥品註冊相關的法律法規要求，藥物在獲得藥物臨牀試驗批准通知書後，尚需開展臨牀試驗並經國家藥監局審評、審批通過後方可生產上市。
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